deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT00025376

PS-341 in Treating Patients With Metastatic Kidney Cancer

A Phase II Trial of PS-341 in Patients With Renal Cell Cancer

Sponsor: National Cancer Institute (NCI)

Conditions Kidney Cancer
Updated 7 times since 2017 Last updated: Sep 4, 2013 Started: Oct 31, 2001 Primary completion: Sep 30, 2002 Completion: Mar 31, 2006
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00025376, this PHASE2 trial focuses on Kidney Cancer and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 7 times since 2001, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

OBJECTIVES: * Determine the objective response rate in patients with metastatic renal cell cancer treated with bortezomib. * Determine the time to tumor progression and 1-year survival of patients treated with this drug. * Determine the toxicity profile of this drug in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive bortezomib IV over 3-5 seconds twice weekly on weeks 1 and 2. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo core biopsy. * Arm II: Patients undergo core biopsy. Patients then receive bortezomib IV as in arm I. Patients undergo radiologic re-evaluation of measurable lesions. Patients with stable disease or a partial or complete response continue to receive bortezomib in the absence of disease progression or unacceptable toxicity. Patients are followed for 2 years. PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 9-14 months.

OBJECTIVES:

* Determine the objective response rate in patients with metastatic renal cell cancer treated with bortezomib. * Determine the time to tumor progression and 1-year survival of patients treated with this drug. * Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive bortezomib IV over 3-5 seconds twice weekly on weeks 1 and 2. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo core biopsy. * Arm II: Patients undergo core biopsy. Patients then receive bortezomib IV as in arm I.

Patients undergo radiologic re-evaluation of measurable lesions. Patients with stable disease or a partial or complete response continue to receive bortezomib in the absence of disease progression or unacceptable toxicity.

Patients are followed for 2 years.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 9-14 months.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Oct 2001

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • University of Chicago
Data source: University of Chicago

For direct contact, visit the study record on ClinicalTrials.gov .